Complying With Final Rule Revising the Common Rule for Clinical Trials and Human Research

Recording of a 90-minute CLE webinar with Q&A


Conducted on Tuesday, February 28, 2017

Recorded event now available

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Program Materials

This CLE webinar will provide guidance to counsel for navigating the changes to the Common Rule for clinical trials and human subjects research. The panel will examine the practical impact for stakeholders, such as hospitals, research organizations and drug manufacturers, and will outline compliance strategies to meet the new requirements.

Description

On Jan. 19, 2017, the U.S. Department of Health and Human Services (HHS) and 15 other federal departments and agencies published a final rule to revise the Federal Policy for the Protection of Human Subjects (the Common Rule), which governs research involving human subjects. The majority of the rule’s provisions take effect in Jan. 2018.

The Common Rule has been in place since 1991, and the revisions provide a regulatory update in light of the many changes in the healthcare and life sciences industries since that time. The final rule addresses issues concerning informed consent, secondary research use of information and biospecimens, harmonization with the HIPAA Privacy Rule, review of multi-site research, and more.

Attorneys advising stakeholders in healthcare and the life sciences, including drug and device manufacturers, hospitals, academic medical centers, universities and medical schools, and institutional review boards, must fully understand the scope and complexity of the changes to the Common Rule to ensure clients are in full compliance.

Listen as our authoritative panel examines the changes to the Common Rule for clinical trials and human research. The panel will provide guidance on the new requirements and discuss the impact on stakeholders involved in clinical trials and human research. The panel will outline compliance strategies to meet the new requirements.

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Outline

  1. Common Rule changes
  2. Impact on the regulatory landscape
  3. What providers and counsel need to do to ensure compliance

Benefits

The panel will review these and other key issues:

  • How do the revisions to the Common Rule change the requirements for human subjects research, including clinical trials?
  • What will the practical impact be on organizations involved in clinical trials or human research?
  • What steps must healthcare industry stakeholders take to ensure compliance by Jan. 2018?

Faculty

Abram S. Barth, Esq.
Abram S. Barth, Esq.

Ropes & Gray

Mr. Barth has a wide range of experience counseling on FDA regulation, with a particular focus on medical devices,...  |  Read More

Emily Marcus Levine
Emily Marcus Levine
Senior Attorney
U.S. Department of Health and Human Services

Ms. Levine is a Senior Attorney with the Public Health Division of the Office of the General Counsel, U.S. Department...  |  Read More

Laura Odwazny
Laura Odwazny
Senior Attorney
U.S. Department of Health and Human Services

Ms. Odwazny’s primary client is the Office for Human Research Protections, which interprets and enforces the HHS...  |  Read More

Peloquin, David
David Peloquin, Esq.

Ropes & Gray

Mr. Peloquin works with the firm’s Corporate Department, primarily on healthcare matters, and particularly in the...  |  Read More

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